The effect of haloperidol's perioperative application on postoperative delirium in elderly patients: a systematic review and meta-analysis.

OBJECTIVES: To systematically review the evidence about the effect of haloperidol on postoperative delirium in elderly patients. METHODS: PubMed, Embase, the Cochrane Library and China National Knowledge Infrastructure were used to find concerned studies for meta-analysis. The main outcome was the incidence of postoperative delirium, and the secondary outcomes were side effects of haloperidol and the length of hospital stay. The meta-analyses were conducted using the Review Manager Version 5.1. This study was conducted based on the PRISMA statement. RESULTS: Eight RCTs (1569 patients) were included in the meta-analysis. There was a significant difference in the incidence of postoperative delirium between haloperidol and control groups (OR = 0.62, 95%CI 0.48-0.80, P = 0.0002, I2 = 20%). In addition, side effects of haloperidol and the duration of hospitalization were comparable (OR = 0.58, 95%CI 0.25-1.35, P = 0.21, I2 = 0%; MD =-0.01, 95%CI -0.16-0.15, P = 0.92, I2 = 28%). Subgroup analysis implied the effect of haloperidol on postoperative delirium might vary with the dose (5 mg daily: OR = 0.40, 95%CI 0.22-0.71, P = 0.002, I2 = 0%; <5 mg daily: OR = 0.72, 95%CI 0.42-1.23, P = 0.23, I2 = 0%). CONCLUSIONS: The meta-analysis revealed perioperative application of haloperidol could decrease the occurrence of postoperative delirium without obvious side effects in elderly people, and high-dose haloperidol (5 mg daily) possessed a greater positive effect.

Effect of accelerated rehabilitation nursing programmes on surgical site wound infection in patients undergoing laparoscopic cholecystectomy: A meta-analysis.

This study aims to evaluate the effect of an accelerated rehabilitation nursing programme on the incidence of surgical site wound infections in patients undergoing laparoscopic cholecystectomy. Relevant studies regarding the use of an accelerated rehabilitation nursing programme in laparoscopic cholecystectomy were retrieved from databases, including PubMed, Web of Science, the Cochrane Library, EMBASE, CNKI and Wanfang Database. The search was conducted from the inception of each database until June 2023. Two independent researchers performed the literature screening, data collection and quality assessment of the included studies. Odds ratio (OR) and 95% confidence interval (CI) were used as the measures of effect. Statistical analysis was conducted using Stata 17.0, and a sensitivity analysis and publication bias evaluation were performed. A total of 21 studies involving 2480 patients (1179 in the intervention group and 1301 in the control group) were included. The meta-analysis revealed that the incidence of surgical site wound infections in the intervention group was significantly lower than in the control group (1.18% vs. 5.99%, OR: 0.322, 95% CI: 0.168-0.556, p < 0.001). Current evidence suggests that implementing accelerated rehabilitation nursing programmes for patients undergoing laparoscopic cholecystectomy has a clinically significant effect, leading to a substantial reduction in the incidence of surgical site wound infections. However, owing to the low quality of some of the included studies, further high-quality, multicentre, large-sample randomised controlled trials are required to validate the conclusions of this study.

Barriers and facilitators of implementing the practice programme for upright positions in the second stage of labour: A mixed-method study.

OBJECTIVE: To explore the possible barriers and facilitators to implementing the Upright Positions in the Second Stage of Labour (UPSSL) programme in Chinese healthcare settings. DESIGN: A mixed-method convergent design with the guidance of Consolidated Framework for Implementation Research (CFIR). METHODS: An online survey study and semi-structured interviews were conducted between March and May 2023. Healthcare professionals were recruited from four hospitals in Shijiazhuang, China. One hundred and thirty-one participants completed the survey study, and 23 of them were interviewed individually. Descriptive statistics evaluated the possible barriers and facilitators of implementing the UPSSL programme within the CFIR framework quantitatively. Guided by the CFIR framework, qualitative data were analysed using directed content analysis to summarize healthcare professionals' perspectives on barriers and facilitators of the UPSSL programme. RESULTS: Multiple intersectional barriers and facilitators were identified from the survey and semi-interviews. Healthcare professionals believed that the UPSSL programme has a scientific evidence base, systematic contents, and possible benefits for women. However, various barriers existed at individual, system, and organizational levels. Major barriers included healthcare professionals and women's safety concerns towards the use of upright positions during childbirth, the healthcare professionals' unfamiliarity with assisting an upright position birth, poor adaptability of the programme protocol, inadequate facilities and staffing, and a lack of readiness to change in the clinical setting. CONCLUSIONS: To facilitate the implementation of the UPSSL programme in China, tailored antenatal education on upright positions, especially addressing safety-related issues, should be provided to pregnant women, their families, or peers to enhance their understanding of and familiarity with such positions. Healthcare professionals should also be offered adequate training opportunities and necessary facilities. Furthermore, national-level policy changes might be required to address midwifery workforce shortages. Additionally, further research is warranted to select, adapt, and test effective implementation strategies for programme adoption. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: What problem did the study address? The adoption of upright positions during the second stage of labour could promote better maternal and neonatal outcomes and a positive childbirth experience. However, the adoption of upright positions during the second stage of labour is suboptimal in healthcare settings in China. Barriers and facilitators of implementing upright positions during childbirth are unclear. What were the main findings? A range of barriers and facilitators within the CFIR framework to promote upright positions during childbirth from healthcare professionals' perspectives were identified, and the major barriers included safety concerns towards and unfamiliarity with an upright position birth, inadequate facilities and staffing, and a lack of readiness to change in the clinical setting. Where and on whom will the research have an impact? This study will enable a better understanding of the barriers and facilitators to promoting upright positions in the second stage of labour in China. The smooth and effective implementation of the UPSSL programme could help to promote better maternal and neonatal outcomes and improve women's childbirth experiences. REPORTING METHOD: The reporting of this study followed the Consolidated Criteria for Reporting Qualitative Research (COREQ) and Good Reporting of A Mixed Methods Study (GRAMMS) guidelines. PATIENT OR PUBLIC CONTRIBUTION: In this study, healthcare professionals were involved in refining the topic guides and survey questions. Additionally, findings from the interviews were returned to them for comments and corrections.

Chemokine (C-C Motif) Ligand 2/Chemokine Receptor 2 (CCR2) Axis Blockade to Delay Chondrocyte Hypertrophy as a Therapeutic Strategy for Osteoarthritis.

BACKGROUND Chondrocytes play a vital role in the later stages of osteoarthritis (OA). The roles of chemokine (C-C motif) ligand 2 (CCL2) and its receptor, chemokine receptor 2 (CCR2), are as yet poorly elucidated in chondrocyte hypertrophy (CH). Here, we aimed to regulate the CCL2/CCR2 axis and explore its effect on progression of CH. MATERIAL AND METHODS Chondrocytes isolated from patients with OA were used in the present study. In vitro experiments were conducted to test hypertrophic gene and CCL2/CCR2 expression in chondrocyte degeneration caused by interleukin (IL)-17A or CCL2 protein stimulation. In addition, inhibition of CCL2 and CCR2 was used to assess the role of CCL2 and CCR2 blockade in CH. Relative gene expression was determined with real-time polymerase chain reaction, western blot, or immunofluorescence. Hypertrophic changes were assessed with cell area measurement. Moreover, the viability of chondrocytes was analyzed using an MTT assay and flow cytometry was used to assess cell apoptosis. RESULTS CCL2 and CCR2 were upregulated in IL-17A-treated chondrocytes. The exogenic CCL2 stimulation also promoted CH and increased the expression of Type 10 collagen, RUNX2, and IHH, which could be reversed via suppression of CCR2. Inhibition of CCL2 and CCR2 expression was sufficient to: 1) protect Type 2 collagen synthesis; 2) alleviate IL-17A-induced overexpression of Type 10 collagen, RUNX2, and IHH; and 3) improve chondrocyte proliferation and apoptosis. CONCLUSIONS Blockading the CCL2/CCR2 axis plays a role in delaying the development of CH.

Mesial temporal extraventricular neurocytoma: a rare cause of refractory complex partial seizure.

AIM: Mesial temporal extraventricular neurocytoma (mtEVN) is a rare cause of refractory complex focal seizures. The characteristics of this clinical entity are discussed in this article. METHODS: We report two cases of mtEVN and review the related literature, with particular emphasis on radiological characteristics, clinical features, and operative techniques. RESULTS: After successful surgery, our two cases of mtEVN achieved excellent outcome. Including the cases presented here, a total of three cases of mtEVNs and 11 of neocortical temporal extraventricular neurocytoma (ntEVNs) are reported in the literature. mtEVNs are distinct from ntEVNs with regards to demographics, aetiology, radiological features, and operative techniques. CONCLUSION: mtEVNs and ntEVNs exhibit distinguishing features. Under electrocorticographic monitoring, tailored resection of the neocortical epileptogenic focus, as well as the entire tumour and mesial temporal structures, can yield excellent outcome and satisfactory seizure control.

[Early effectiveness of arthroscopic tri-anchor double-pulley suture-bridge repair of medium-size supraspinatus tendon tears].

Objective: To explore the early effectiveness of arthroscopic tri-anchor double-pulley suture-bridge in treatment of medium-size supraspinatus tendon tears. Methods: Between December 2020 and January 2023, 40 patients with medium-size supraspinatus tendon tears were treated with arthroscopic tri-anchor double-pulley suture-bridge. There were 18 males and 22 females, with an average age of 62.6 years (mean, 45-73 years). Among them, 17 patients had trauma history. The main clinical symptom was shoulder pain with hug resistance test (+). The interval from symptom onset to operation was 10.7 months on average (range, 3-36 months). Visual analogue scale (VAS) score, University of California Los Angeles (UCLA) score, American Shoulder and Elbow Surgeons (ASES) score, and shoulder range of motion (ROM) of forward flexion, abduction, and external rotation were used to evaluate shoulder function. MRI was performed to assess the structural integrity and tension of reattached tendon. Patient satisfactions were calculated at last follow-up. Results: All incisions healed by first intention, no complications such as incision infection or nerve injury occurred. All patients were followed up 12-37 months (mean, 18.2 months). At 12 months after operation, VAS score, UCLA score, and ASES score significantly improved when compared with the preoperative scores ( P<0.05). At 3 and 12 months after operation, the ROM of external rotation significantly improved when compared with preoperative one ( P<0.05), and further improved at 12 months after operation ( P<0.05). However, the ROMs of abduction and forward flexion did not improve at 3 months after operation when compared with those before operation ( P>0.05), but significantly improved at 12 months after operation ( P<0.05). Twenty-six patients underwent MRI at 3-6 months, of which 23 patients possessed intact structural integrity, good tendon tension, and tendon healing; 3 patients underwent tendon re-tear. The self-rated satisfaction rate was 92.5% at last follow-up. Conclusion: Arthroscopic tri-anchor double-pulley suture-bridge in treatment of medium-size supraspinatus tendon tears can maximize the tendon-bone contact area, obtain satisfied early effectiveness with high satisfaction rate and low incidence of tendon re-tear. However, the function of abduction is limited at 3 months after operation, and patients need to adhere to rehabilitation training to further improve the joint activity.

Biodiversity of the beneficial soil-borne fungi steered by Trichoderma-amended biofertilizers stimulates plant production.

The soil microbiota is critical to plant performance. Improving the ability of plant-associated soil probiotics is thus essential for establishing dependable and sustainable crop yields. Although fertilizer applications may provide an effective way of steering soil microbes, it is still unknown how the positive effects of soil-borne probiotics can be maximized and how their effects are mediated. This work aims to seek the ecological mechanisms involved in cabbage growth using bio-organic fertilizers. We conducted a long-term field experiment in which we amended soil with non-sterilized organic or sterilized organic fertilizer either containing Trichoderma guizhouense NJAU4742 or lacking this inoculum and tracked cabbage plant growth and the soil fungal community. Trichoderma-amended bio-organic fertilizers significantly increased cabbage plant biomass and this effect was attributed to changes in the resident fungal community composition, including an increase in the relative abundance and number of indigenous soil growth-promoting fungal taxa. We specifically highlight the fundamental role of the biodiversity and population density of these plant-beneficial fungal taxa in improving plant growth. Together, our results suggest that the beneficial effects of bio-organic fertilizer seem to be a combination of the biological inoculum within the organic amendment as well as the indirect promotion through effects on the diversity and composition of the soil resident plant-beneficial fungal microbiome.

Left Bundle Branch Pacing for Heart Failure and Left Bundle Branch Block Patients With Mildly Reduced and Preserved Left Ventricular Ejection Fraction.

BACKGROUND: Left bundle branch block (LBBB) may induce or aggravate heart failure (HF). Few data are available on patients with HF and LBBB with mildly reduced ejection fraction (HFmrEF; left ventricular ejection fraction [LVEF] 40%-50%) and those with preserved EF (HFpEF. LVEF ≥ 50%). We aimed to assess the long-term outcomes of left bundle branch pacing (LBBP) on cardiac function and remodelling in patients with LBBB and symptomatic HFmrEF and HFpEF. METHODS: Nonischemic cardiomyopathy (NICM) patients with HFmrEF and HFpEF (LVEF from 40% to 60% as defined with the use of echocardiography) with LBBB who successfully underwent LBBP (n = 50) were prospectively included from 4 centres. Patient characteristics and echocardiographic and lead parameters were recorded at implantation and during follow-ups of 1, 3, 6, and 12 months. RESULTS: All patients completed 1-year follow up. The LVEF was significantly improved from 46.5 ± 5.2% at baseline to 60.0 ± 6.1% (n = 50; P < 0.001) after 1-year follow up. Higher ΔLVEF and super-response rate were observed in the HFmrEF group (n = 30) than in the HFpEF group (n = 20). CONCLUSIONS: LBBP improved symptoms and reversed remodelling in patients with LBBB and symptomatic HF at 1-year follow-up. Improvement occurred even in HFpEF patients, and the resynchronisation effect was better in HFmrEF group.

Odour emission ability (OEA) and its application in assessing odour removal efficiency.

Odourous emissions from sewer networks and wastewater treatment plants (WWTPs) can significantly impact a local population. Sampling techniques such as wind tunnels and flux hood chambers are traditionally used to collect area source samples for subsequent quantification of odour emission rates using dilution olfactometry, however these methods are unsuitable for assessing liquid samples from point sources due to the large liquid volumes required. To overcome this limitation, a gas phase sample preparation method was developed for assessing the total Odour Emission Ability (OEA) from a liquid sample. The method was validated using two volatile organic sulphur compounds (VOSCs), dimethyl-trisulphide (DMTS) and bismethylthiomethane (BMTM) that are frequently detected from sewers and WWTPs and are relatively stable compared with common VOSCs like mercaptan or methyl mercaptan. The recovery rates of DMTS and BMTM were quantified by injecting a known volume of a standard liquid sample into Tedlar bags using a static injection and a dynamic injection methodology. It was confirmed that both dynamic and static injection methods at ambient condition achieved high recovery rates with no need to consider increasing evaporation by elevating the temperature. This method can also be used to assess odour removal effectiveness of liquids by comparing the OEA before and after the treatment tests. Two application examples were presented.

Acceptability of HIV pre-exposure prophylaxis in China: A systematic review and meta-analysis.

Using pre-exposure prophylaxis (PrEP) for the prevention of HIV infection is a popular, contemporary research topic. We retrieved PubMed, Web of Science, MEDLINE, Wanfang, CNKI, and Sinomed databases, and related websites to identify studies both in Chinese and English, which reported the acceptability of PrEP in China. A total of 3203 citations were retrieved, of which 54 were included. We found that the acceptability varied widely across the country, ranging from 19.1% to 94.6%, and the pooled estimate was 66.8% (95% CI: 62.0%-71.3%). Higher acceptability of PrEP was associated with the following factors: individuals with a lower educational degree, higher income, non-discriminatory attitude towards AIDS or AIDS patients, self-perceived high HIV risk, feeling that PrEP should be promoted, familiarity with PrEP, history of HIV testing, history of anal intercourse, consistent condom use, higher number of sexual partners. The main reasons for not using PrEP are doubting its validity, fear of potential side effects and financial burden, and fear of stigma for using PrEP. This review found that the acceptance in China was moderate.

Analytical technology development to monitor the stability of Polysaccharide-Protein conjugate vaccines.

The covalent attachment of a bacterial-derived capsular polysaccharide to protein is of critical importance in transforming the polysaccharide from an antigen with limited immunogenicity in infants and older adults to an antigen that can prevent potentially fatal disease. For a polysaccharide-protein conjugate vaccine (PCV) candidate to be successful, it must be sufficiently stable. Chemical breakage of carbohydrate bonds in the polysaccharide may result in the reduction of "conjugate dose" and could negatively impact immunogenicity and the ability of the vaccine to prime for memory responses. Therefore, development of analytical tools to monitor the integrity of a polysaccharide-protein conjugate (glycoconjugate) vaccine is of practical significance. In this work, reducing SDS-PAGE, Intrinsic Protein Fluorescence Spectroscopy (IPFS), Differential Scanning Fluorimetry (DSF) were evaluated methods to study the impact of time, temperature, and formulation composition on the stability of a glycoconjugate vaccine prepared by multisite coupling of polysaccharide to a carrier protein. In addition, an automated capillary Western system was also evaluated to study the impact of storage on glycoconjugate vaccine stability. Two streptococcus pneumoniae polysaccharide-protein conjugates (serotype 3 and serotype 19A) were chosen to examine their physicochemical stability when formulated as a single antigen vaccine. While all methods require only a small amount of test article and can test multiple samples per assay run, automated capillary Western has the additional advantage of being highly sensitive even at low concentrations in complex vaccine formulations that contain aluminum adjuvant and multiple antigens. Results suggest that automated capillary Western is stability-indicating and may be an effective analytical technology tool for the formulation development of a multivalent glycoconjugate vaccine.

[Clinical observation of electroacupuncture combined with Qingyi Xianxiong Decoction in the treatment of acute respiratory distress syndrome due to severe acute pancreatitis].

OBJECTIVE: To observe the clinical effect of electroacupuncture combined with Qingyi Xianxiong Decoction on the treatment of acute respiratory distress syndrome (ARDS) caused by severe acute pancreatitis (SAP). METHODS: From February 2021 to April 2022, 120 patients with ARDS caused by SAP who were admitted to the department of critical care medicine of Tianjin Nankai Hospital and whose syndrome differentiation belonged to the syndrome of knot chest were selected. They were randomly divided into pure traditional Chinese medicine group and acupuncture medicine group, with 60 cases in each group. The pure traditional Chinese medicine group was received Qingyi Xianxiong Decoction on the basis of conventional western medicine treatment, and the acupuncture medicine group was received electric acupuncture treatment on the basis of the pure traditional Chinese medicine group. The two groups continued to be treated for 7 days. The primary outcome was the ventilator-free days within 28 days after admission to the intensive care unit (ICU), and the secondary outcome measures were mechanical ventilation time, the length of ICU stay, total lenth of hospital stay, time of intra-abdominal pressure recovery, scores of organ function, oxygenation index (PaO2/FiO2), serum inflammatory factors, blood amylase, urine amylase, etc. RESULTS: Compared with the pure traditional Chinese medicine group, the ventilator-free days in the acupuncture medicine group within 28 days after admission to the ICU were significantly longer [day: 22.10±2.29 vs. 20.97±2.31, P < 0.05, odds ratio (OR) = 1.24, 95% confidence interval (95%CI) was 1.053-1.460, P < 0.05]. The time of mechanical ventilation, the length of ICU stay, total length of hospital stay, and recovery time of intra-abdominal pressure were significantly shortened [mechanical ventilation time (days): 5.90±2.29 vs. 7.03±2.31, the length of ICU stay (days): 8.07±1.89 vs. 12.08±2.23, total length of hospital stay (days): 19.55±6.82 vs. 22.28±5.19, recovery time of intra-abdominal pressure (days): 6.05±1.81 vs. 8.45±1.76, all P < 0.05]. The Murray score and bedside index for severity in acute pancreatitis (BISAP) score of the two groups after 7 days of treatment were significantly lower than those before treatment, while PaO2/FiO2 was significantly higher than those before treatment, and the Murray score of the acupuncture medicine group after 7 days of treatment was significantly lower than that of the pure traditional Chinese medicine group [score: 0.50 (0.33, 0.75) vs. 1.00 (1.00, 1.33), P < 0.05], PaO2/FiO2 was significantly higher than that in the pure traditional Chinese medicine group [mmHg (1 mmHg ≈ 0.133 kPa): 390.75±27.73 vs. 330.02±42.34, P < 0.05]. With the prolongation of treatment time, the levels of inflammatory factors such as tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), C-reactive protein (CRP), serum amylase and urine amylase in both groups after treatment continued to decrease, and the levels of the inflammatory factors in the acupuncture medicine group after 7 days of treatment were significantly lower than those in the pure traditional Chinese medicine group [TNF-α (ng/L): 38.20±10.00 vs. 45.35±5.09, IL-6 (ng/L): 0.95±0.44 vs. 7.42±1.39, CRP (mg/L): 8.55±2.79 vs. 36.20±13.97, all P < 0.05]. Subgroup analysis showed that biliary system disease was a risk factor for the duration of mechanical ventilation ≥ 7 days in the treatment of ARDS with acupuncture and medicine (OR = 2.728, 95%CI was 1.293-5.754). CONCLUSIONS: Compared with the pure traditional Chinese medicine, acupuncture combined can better reduce the clinical symptoms of patients with ARDS caused by SAP, promote the recovery of patients, and reduce systemic inflammatory reaction, which is worthy of clinical promotion.

Outcomes of an outpatient home-based prehabilitation program before pancreaticoduodenectomy: A retrospective cohort study.

Backgrounds/Aims: Prehabilitation aims for preoperative optimisation to reduce postoperative complications. However, there is a paucity of data on its use in patients undergoing pancreaticoduodenectomy (PD). Thus, this study aims to evaluate the outcomes of a home-based outpatient prehabilitation program (PP) versus no-PP in patients undergoing PD. Methods: This retrospective cohort study compared patients who underwent PP versus no-PP before elective PD from January 2016 to December 2020. Inclusion criteria for PP were < 65 years or 65-74 years with FRAIL score < 3. No-PP included dietician, case manager and anesthesia review. PP included additional physiotherapy sessions, caregiver training and interim phone consultation. Univariate and multivariate analysis were used to evaluate length of stay (LOS), morbidity, 30-day readmission, and 90-day mortality. Results: Seventy-one patients (PP: n = 50 [70.4%]; no-PP: n = 21 [29.6%]) were included in this study. Median age was 65 years (interquartile range [IQR]: 58-72 years). Majority (n = 58 [81.7%]) of patients underwent open surgery. Ductal adenocarcinoma was the most common histology (49.3%). Patient demographics were comparable between both groups. Overall median LOS was 11.0 days (IQR: 8.0-17.0 days). Compared to no-PP, PP was not independently associated with reduced intra-abdominal collections (odds ratio [OR]: 0.43; 95% confidence interval [CI]: 0.03-6.11, p = 0.532), major morbidity (OR: 1.31; 95% CI: 0.09-19.47; p = 0.845) or 30-day readmission (OR: 3.16; 95% CI: 0.26-38.27; p = 0.365). There was one (1.4%) 30-day mortality. Conclusions: Our outpatient PP with unsupervised exercise regimes did not improve postoperative outcomes following elective PD.

Effects of foliar application of amino acid liquid fertilizers, with or without Bacillus amyloliquefaciens SQR9, on cowpea yield and leaf microbiota.

Leaf surface fertilization with liquid fertilizer produced from amino acids constitutes a potentially important source of nitrogen and is important for plant production. However, few reports have focused on the plant growth promotion by novel liquid fertilizers created by new amino acid resources, let alone the influence on leaf microbiota. In this study, the effects of liquid fertilizer, created by amino acids hydrolyzed from animal hairs with or without the PGPR strain Bacillus amyloliquefaciens SQR9, on crop yield and leaf microbiota were investigated. The results showed that leaves sprayed with amino acid liquid fertilizer (AA) and liquid biological fertilizer (AA9) persistently increased cowpea yields compared to the control amended with chemical fertilizer (CF). Fertilization with amino acid fertilizer showed no significant difference in microbial composition compared with the CF treatment; however, the introduction of functional microbes altered the microbial composition. Pearson correlation analysis, VPA analysis and SEM models all revealed that the amino acids liquid fertilizer application, but not the functional strain or the altered microbiota, performed as the direct driver attributing to yield enhancement. We conclude that leaf fertilization with a novel amino acid liquid fertilizer can greatly enhance the crop yield and that the addition of beneficial microbes may perform the role in further altering the composition of leaf microbiota.

Development of a Subcutaneous Fixed-Dose Combination of Pertuzumab and Trastuzumab: Results From the Phase Ib Dose-Finding Study.

Adding pertuzumab to trastuzumab (both monoclonal antibodies targeting human epidermal growth factor receptor 2 [HER2]) has proven survival benefits when combined with chemotherapy for patients with HER2-positive breast cancer. The combination of pertuzumab and trastuzumab together in 1 vial for subcutaneous (SC) administration is being developed as a ready-to-use formulation to reduce the treatment burden on patients while improving healthcare efficiency. An open-label, 2-part, phase Ib dose-finding study (NCT02738970) was undertaken in healthy male volunteers (part 1) and female patients with HER2-postive early breast cancer who had completed standard (neo)adjuvant treatment (part 2). This study aimed to identify an SC pertuzumab dose given with recombinant human hyaluronidase that results in comparable exposure to that of the intravenous (IV) pertuzumab dose, based on pertuzumab serum trough concentration and area under the serum concentration-time curve. Pharmacokinetics (PK), safety, and tolerability of a single dose of SC pertuzumab given alone or in a fixed-dose combination (comixed or coformulated) with trastuzumab were also assessed. A maintenance dose of 600 mg for SC pertuzumab resulted in an equivalent exposure to that of IV pertuzumab, and no new safety signals were identified for SC pertuzumab or trastuzumab. A loading dose of 1200 mg for SC pertuzumab was selected based on approximate dose proportionality. The PK and safety results support further development of a fixed-dose coformulation combination of pertuzumab and trastuzumab for SC administration, which will be investigated in an upcoming phase III trial in patients with HER2-positive early breast cancer.

[Modified incision to prevent the postoperative spinal lateral angulation in surgery via anterior approach for lumbar fracture].

OBJECTIVE: To explore a method of modified incision to prevent the postoperative spinal lateral angulation via anterior approach for lumbar fracture. METHODS: A total 40 patients with lumbar fracture from January 2016 to Jun 2017 were internalized in the study. Including 28 males and 12 females, aged from 27 to 68 years with an average of (39.5±14.9) years. Among them, 28 cases caused by high fall, 9 cases by heavy injury, 3 cases by traffic accidents; and 35 fractures were located at L1,4 at L2,1 at L3. All the fractures were type A based on AO classification. According to Frankel classify of spinal cord injury, 5 cases were grade A, 1 case was B, 10 cases were C, 15 cases were D, 9 cases were E. The patients were divided randomly into modified incision groups and routine incision groups. All patients were treated with decompression, internal fixation and titanium mesh supported bone graft fusion via anterior approach. All the internal fixation materials were ANTERIOR (Medtronic Inc). Incision direction and incision plane were improved in modified incision groups. The coronal Cobb angle and the angle between the vertebral screw and the corresponding endplate were analyzed before and after operation. RESULTS: Pre-and post-operative coronal Cobb angles were (1.20±3.26) °, ( 2.16±3.55)° in modified incision groups and(1.22±4.42)°, (3.91±3.78)° in routine incision groups respectively. And there was no statistical difference before operation, and there was statistical difference after operation between two groups(P=0.017). There was no lateral angulation of more than 5 degrees in modified incision group, but there was lateral angulation of 5 to 10 degrees in routine incision group in 6 cases. The incidence of lateral angulation about 5 degrees after operation was significantly different between two groups (P=0.010). There was significant difference in the angle between the proximal two vertebral screws and the corresponding endplate between two groups (P<0.05), but there was no significant difference in the angle between the distal two vertebral screws and the corresponding endplate (P>0.05). CONCLUSIONS: The improvement of incision direction and plane can effectively prevent the postoperative spinal lateral angulation via anterior approach for lumbar fracture.

[Clinical observation of depression after breast cancer operation treated with aurieular point sticking therapy].

OBJECTIVE: To compare the differences in the efficacy on depression after breast cancer operation treated with auricular point sticking therapy, the combined program of auricular point sticking therapy and TCM psychotherapy and medication with deanxit. METHODS: Ninety patients were randomized into 3 groups, 30 cases in each one. In the western medication group, the simple oral administration of deanxit was applied, one tablet a day. In the auricular point group, Xin (GO15), Shen (CO10), Gan(CO12), Shenmen(TF4), Pizhixia (AT), Neifenmi (CO18) were selected and stimulated with auricular point sticking on either side in each treatment, once a week. In the combined program group, on the basis of the treatment as the auricular point group, TCM psychotherapy was combined with. The treatment of 4 weeks made one session. One session and 4 weeks follow-up were required. The self-rating depression scale (SDS) was used to compare the score before and after treatment in the patients of each group and the efficacy was assessed. RESULTS: (1) Compared with those before treatment, in 4 weeks of treatment and 4 weeks of follow-up, SDS scores were all reduced apparently in the 3 groups (all P<0.001). After 4 weeks of follow-up in the auricular point group, after 2 and 4 weeks of treatment and 4 weeks of follow-up in the combined program group, SDS scores were all lower than those in the western medication group (all P<0.05). (2) After 4 weeks of treatment, the curative rate in the combined program group was higher than that in the auricular point group and the western medication group [60.0% (18/30) vs. 40.0% (12/30), 36.7% (11/30), both P<0.05)]. After 4 weeks of follow-up, the curative rate in either the combined program group or the auricular point group was higher than that in the western medication group [60.0% (18/30), 30.0% (19/30) vs. 23.3% (7/30), both P<0.05]. CONCLUSION: The auricular point sticking therapy, the combined program of auricular point sticking therapy and TCM psychotherapy, and medication with deanxit all relieve depression after breast cancer operation. The efficacy of the combined program with auricular point sticking therapy and TCM psychotherapy involved is the best, and the efficacy of the auricular point sticking therapy is better than the oral administration of deanxit.

[Definitive postponed surgery for the casualties with multiple injuries in the earthquake].

OBJECTIVE: To explore the treatment of casualties who suffered from multiple injuries in earthquake and had been treated by damage control (DC) immediately,and the definite postponed surgery time by way of APACHE II score. METHODS: From May to June 2008, 21 casualties who had undergone DC accepted further treatment of medicine and surgery, and recovered physical potentiality in the intensive care unit (ICU). APACHE II score was adopted to evaluate the casualties' physical potentiality. Then, internal fixation of intra-articular fractures and centrum fractures, alternation from external fixation to internal fixation, reconstruction of soft tissue was applied by stages according to the plan. RESULTS: All the patients were effectively cured after definite postponed surgery. There was less complication, low deformity ratio and no death happened. CONCLUSION: Timely evaluation of the casualties' physical potentiality, appropriate surgery time and exact surgery can reduce the casualties' complication, deformity rate and death rate.